Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006113
Recruitment Status : Terminated (Lack of efficacy)
First Posted : January 27, 2003
Last Update Posted : May 22, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief Summary:

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen Biological: recombinant CD40-ligand Biological: recombinant interferon gamma Biological: recombinant interleukin-4 Biological: sargramostim Biological: therapeutic autologous dendritic cells Biological: therapeutic tumor infiltrating lymphocytes Biological: tyrosinase peptide Radiation: Candida albicans skin test reagent Phase 2

Detailed Description:


  • Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo.
  • Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Primary Purpose: Treatment
Official Title: A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma
Study Start Date : June 1999
Actual Primary Completion Date : May 2003
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic melanoma

    • Measurable disease after attempted curative surgery
    • Unresectable stage III or IV uveal melanoma
    • Metastatic mucosal melanoma
  • HLA-A2.1 positive
  • No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours)



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 9.0 g/dL
  • No coagulation disorders


  • Bilirubin no greater than 2.0 mg/dL


  • Creatinine no greater than 2.0 mg/dL


  • No myocardial infarction within the past 6 months
  • Patients with documented or suspected coronary artery disease must undergo stress thallium test
  • No major cardiovascular illness


  • No major pulmonary illness


  • HIV negative
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative
  • No history of uveitis or autoimmune inflammatory eye disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No major systemic infection
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer


Biologic therapy:

  • See Disease Characteristics
  • No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens


  • At least 1 month since prior chemotherapy for melanoma

Endocrine therapy:

  • No concurrent steroid therapy


  • At least 1 month since prior radiotherapy for melanoma


  • See Disease Characteristics


  • At least 1 month since prior adjuvant therapy for melanoma
  • At least 1 month since other prior therapy for melanoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006113

United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Study Chair: Jeffrey S. Weber, MD, PhD University of Southern California

Responsible Party: University of Southern California Identifier: NCT00006113     History of Changes
Other Study ID Numbers: CDR0000068125 (10M-99-1)
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by University of Southern California:
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents